title: Impact of the approval of intravenous recombinant tissue plasminogen activator therapy on the processes of acute stroke management in Japan: the Stroke Unit Multicenter Observational (SUMO) Study.
abstract: OBJECTIVE
  The Ministry of Health, Labor, and Welfare of Japan approved the use of recombinant tissue-type plasminogen activator (rt-PA) for the treatment of acute ischemic stroke in October 2005. The impact of the regulatory approval of rt-PA on the processes of acute stroke management was examined.
  
  
  METHODS
  A prospective, multicenter, observational study was conducted between December 2004 and December 2005 in 84 Japanese institutes, including 24 institutes with a stroke unit. We enrolled 4620 consecutive patients who were hospitalized within 72 hours after the onset of completed ischemic stroke; 1089 of them were hospitalized after rt-PA was approved. The patients' characteristics and the processes of stroke management were compared before and after rt-PA approval.
  
  
  RESULTS
  Age, gender, stroke subtype, time from onset to hospital visit, and National Institutes of Health Stroke Scale score on admission were similar between the 2 periods. With approval, the percentage of patients treated with intravenous rt-PA therapy increased from 0.7% to 2.6% (P<0.001). The rate increased from 0.9% to 5.2% in institutes with a stroke unit (P<0.001) but did not increase in other institutes (P=0.587). Within 24 hours of stroke onset, conventional MRI (P=0.003), diffusion-weighted MRI (P<0.001), magnetic resonance angiography (P=0.001), carotid ultrasound (P=0.004), measurement of prothrombin time or activated partial thromboplastin time (P=0.034), and measurement of blood sugar (P=0.015) were performed more frequently after rt-PA approval.
  
  
  CONCLUSIONS
  The present results indicate that the approval of intravenous rt-PA therapy resulted in dramatic changes in the processes of management for acute stroke patients.
authors.affiliation: Cerebrovascular Division, Department of Medicine, National Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan.
authors.forename: Shoichiro
authors.initials: S
authors.lastname: Sato
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Uehara
authors.forename: Kazunori
authors.initials: K
authors.lastname: Toyoda
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yasui
authors.forename: Takashi
authors.initials: T
authors.lastname: Hata
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Ueda
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okada
authors.forename: Akihiro
authors.initials: A
authors.lastname: Toyota
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Naritomi
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
mesh_terms: D000368:Aged; D001921:Brain / Q000098:blood supply / Q000473:pathology; D002340:Carotid Artery Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000473:pathology; D002536:Cerebral Arteries / Q000187:drug effects* / Q000473:pathology; D017277:Drug Approval; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006801:Humans; D007564:Japan; D018810:Magnetic Resonance Angiography; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D011517:Prothrombin Time; D020521:Stroke / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator